Apparatus and method for calibrating an x-ray image of a knee of a patient

ABSTRACT

An x-ray calibration apparatus includes a radiolucent knee alignment jig configured to receive a knee of a patient and a radiolucent cushion configured to hold a patient&#39;s knee at a fixed angle of flexion. The x-ray calibration apparatus also includes a number of radio-opaque fiducial markers positioned within the radiolucent knee alignment jig.

This application is a divisional application of U.S. patent applicationSer. No. 13/797,131 filed on Mar. 12, 2013, now U.S. Pat. No. 9,241,682,the entirety of which is hereby incorporated by reference.

TECHNICAL FIELD

The present disclosure relates generally to customized patient-specificorthopaedic surgical instruments, and in particular to an x-raycalibration apparatus and method.

BACKGROUND

Joint arthroplasty is a well-known surgical procedure by which adiseased and/or damaged natural joint is replaced by a prosthetic joint.A typical knee prosthesis includes a tibial tray, a femoral component, apolymer insert or bearing positioned between the tibial tray and thefemoral component, and, in some cases, a polymer patella button. Tofacilitate the replacement of the natural joint with the kneeprosthesis, orthopaedic surgeons use a variety of orthopaedic surgicalinstruments such as, for example, cutting blocks, drill guides, millingguides, and other surgical instruments. Typically, the orthopaedicsurgical instruments are generic with respect to the patient such thatthe same orthopaedic surgical instrument may be used on a number ofdifferent patients during similar orthopaedic surgical procedures.

SUMMARY

According to one aspect, an x-ray calibration apparatus includes aradiolucent knee alignment jig configured to receive a knee of apatient. The radiolucent knee alignment jig includes a bottom plate, alateral sidewall secured to and extending upwardly from a lateral sideof the bottom plate, and a medial sidewall secured to and extendingupwardly from a medial side of the bottom plate. The x-ray calibrationapparatus also includes a first plurality of radio-opaque fiducialmarkers positioned within the lateral sidewall and a second plurality ofradio-opaque fiducial markers positioned within the medial sidewall. Thesecond plurality of radio-opaque fiducial markers are positioned suchthat when viewed in an x-ray image taken perpendicularly to the bottomplate, each of the second plurality of radio-opaque fiducial markers aredistinct from the first plurality of radio-opaque fiducial markers, andwhen viewed in an x-ray image taken perpendicularly to the lateralsidewall, each of the second plurality of radio-opaque fiducial markersare distinct from the first plurality of radio-opaque fiducial markers.

In an embodiment, the medial sidewall is shorter than the lateralsidewall.

The x-ray calibration apparatus may also include a radiolucent cushionconfigured to hold a patient's knee at a fixed angle of flexion, thecushion being secured to an upper surface of the bottom plate andpositioned between the lateral sidewall and the medial sidewall.

In an embodiment, the first plurality of radio-opaque fiducial markersincludes an upper lateral plurality of radio-opaque fiducial markers,positioned within the lateral sidewall such that when viewed in an x-rayimage taken perpendicularly to the lateral sidewall, each of the upperlateral plurality of radio-opaque fiducial markers appears above anupper ridge of the radiolucent cushion. The first plurality ofradio-opaque fiducial markers also includes a lower lateral plurality ofradio-opaque fiducial markers, positioned within the lateral sidewallsuch that when viewed in an x-ray image taken perpendicularly to thelateral sidewall, each of the lower lateral plurality of radio-opaquefiducial markers appears below the upper ridge of the radiolucentcushion.

The upper lateral plurality of radio-opaque fiducial markers may consistof three radio-opaque fiducial markers, the lower lateral plurality ofradio-opaque fiducial markers may consist of three radio-opaque fiducialmarkers, and the second plurality of radio-opaque fiducial markers mayconsist of four radio-opaque fiducial markers.

According to another aspect, an x-ray calibration apparatus includes aradiolucent knee alignment jig configured to receive a knee of apatient, the knee alignment jig. The radiolucent knee alignment jigincludes a bottom plate, a lateral sidewall secured to and extendingupwardly from a lateral side of the bottom plate, and a medial sidewallsecured to and extending upwardly from a medial side of the bottomplate. The x-ray calibration apparatus also includes a radiolucentcushion configured to hold a patient's knee at a fixed angle of flexion.The cushion is secured to an upper surface of the bottom plate andpositioned between the lateral sidewall and the medial sidewall. Thex-ray calibration apparatus also includes a first plurality ofradio-opaque fiducial markers, positioned such that when viewed in anx-ray image taken perpendicularly to the lateral sidewall, each of thefirst plurality of radio-opaque fiducial markers appears above an upperridge of the radiolucent cushion; a second plurality of radio-opaquefiducial markers, positioned such that when viewed in an x-ray imagetaken perpendicularly to the lateral sidewall, each of the secondplurality of radio-opaque fiducial markers appears below the upper ridgeof the radiolucent cushion; and a third plurality of radio-opaquefiducial markers positioned such that when viewed in an x-ray imagetaken perpendicularly to the bottom plate, each of the third pluralityof radio-opaque fiducial markers is distinct from each of the first andsecond plurality of radio-opaque fiducial markers, and when viewed in anx-ray image taken perpendicularly to the lateral sidewall, each of thethird plurality of radio-opaque fiducial markers is distinct from eachof the first and second plurality of radio-opaque fiducial markers.

The radiolucent cushion may be marked with intersecting perpendicularlines configured to be aligned with cross-hairs emitted by an x-raysource positioned to create an x-ray image taken perpendicularly to thebottom plate. The lateral sidewall also may be marked with intersectingperpendicular lines configured to be aligned with cross-hairs emitted byan x-ray source positioned to create an x-ray image takenperpendicularly to the lateral sidewall.

In an embodiment, the first plurality of radio-opaque fiducial markersare positioned within the lateral sidewall, the second plurality ofradio-opaque fiducial markers are positioned within the lateralsidewall, and the third plurality of radio-opaque fiducial markers arepositioned within the medial sidewall.

The first plurality of radio-opaque fiducial markers may consist ofthree radio-opaque fiducial markers, the second plurality ofradio-opaque fiducial markers may consist of three radio-opaque fiducialmarkers, and the third plurality of radio-opaque fiducial markers mayconsist of four radio-opaque fiducial markers.

According to another aspect, a method of generating an image for use inthe fabrication of a customized patient-specific orthopaedic kneeinstrument includes positioning a patient's knee on an x-ray calibrationapparatus having a plurality of radio-opaque fiducial markers positionedat fixed distances such that each of the plurality of radio-opaquefiducial markers are distinct from one another when viewed in x-rayimages taken in a direction anterior to the patient's knee, and in adirection lateral to the patient's knee. A first x-ray image is taken ina direction anterior to the patient's knee such that representations ofat least some of the plurality of radio-opaque fiducial markers arevisible in the first x-ray image. A second x-ray image is taken in adirection lateral to the patient's knee such that representations of atleast some of the plurality of radio-opaque fiducial markers are visiblein the second x-ray image. The first and second x-ray images areregistered onto one another using the representations of the pluralityof radio-opaque fiducial markers visible in the first and second x-rayimages.

Registering the first and second x-ray images onto one another mayinclude aligning the first and second x-ray images using therepresentations of the plurality of radio-opaque fiducial markersvisible in the first and second x-ray images.

The method may also include calculating an x-ray scaling factor bymeasuring the distances between two or more of the representations ofthe plurality of radio-opaque fiducial markers visible in one or both ofthe first and second x-ray images, and comparing the distances betweenthe two or more of the representations of the plurality of radio-opaquefiducial markers visible in one or both of the first and second x-rayimages to the distances between the corresponding fiducial markerspositioned in the x-ray calibration apparatus.

The method may also include calculating a beam angle by measuring thedistances between two or more sets of representations of the pluralityof radio-opaque fiducial markers visible in one or both of the first andsecond x-ray images, and comparing the distances between the two or moreof the representations of the plurality of radio-opaque fiducial markersvisible in one or both of the first and second x-ray images to thedistances between the corresponding fiducial markers positioned in thex-ray calibration apparatus.

In an embodiment, the method may include calculating an x-ray scalingfactor by measuring the distance between a first representation of afirst of the plurality of radio-opaque fiducial markers visible in thefirst x-ray image and a second representation of a second of theplurality of radio-opaque fiducial markers visible in the first x-rayimage, and comparing the distance between the first and secondrepresentations to the distance between the first fiducial markerpositioned in the x-ray calibration apparatus and the second fiducialmarker positioned in the x-ray calibration apparatus.

In an embodiment, the method may include calculating an x-ray scalingfactor by measuring the distance between a first representation of afirst of the plurality of radio-opaque fiducial markers visible in thesecond x-ray image and a second representation of a second of theplurality of radio-opaque fiducial markers visible in the second x-rayimage, and comparing the distance between the first and secondrepresentations to the distance between the first fiducial markerpositioned in the x-ray calibration apparatus and the second fiducialmarker positioned in the x-ray calibration apparatus.

In an embodiment, the method may include calculating a beam angle bymeasuring the distances between two or more sets of representations ofthe plurality of radio-opaque fiducial markers visible in the firstx-ray image, and comparing the distances between the two or more of therepresentations of the plurality of radio-opaque fiducial markersvisible in the first x-ray image to the distances between thecorresponding fiducial markers positioned in the x-ray calibrationapparatus.

In an embodiment, the method may include calculating a beam angle bymeasuring the distances between two or more sets of representations ofthe plurality of radio-opaque fiducial markers visible in the secondx-ray image, and (ii) comparing the distances between the two or more ofthe representations of the plurality of radio-opaque fiducial markersvisible in the second x-ray image to the distances between thecorresponding fiducial markers positioned in the x-ray calibrationapparatus.

The method may also include generating a design of the customized,patient-specific orthopaedic knee instrument based on the registeredfirst and second x-ray images.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the following figures,in which:

FIG. 1 is a simplified flow diagram of an algorithm for designing andfabricating a customized patient-specific orthopaedic surgicalinstrument;

FIG. 2 is a simplified flow diagram of a method for generating a modelof a patient-specific orthopaedic instrument;

FIG. 3 is a simplified flow diagram of a method for scaling a referencecontour;

FIGS. 4-6 are three-dimensional model's of a patient's tibia;

FIG. 7-9 are three-dimensional models of a patient's femur;

FIG. 10 is a perspective view of an x-ray calibration apparatus;

FIG. 11 is a perspective view of the x-ray calibration apparatus of FIG.10, showing the radiolucent cushion removed;

FIG. 12 is an anterior elevation view of the x-ray calibration apparatusof FIG. 10 with the radiolucent cushion removed;

FIG. 13 is an elevation view of the x-ray calibration apparatus of FIG.10 with the radiolucent cushion removed;

FIGS. 14-15 are perspective views of the x-ray calibration apparatus ofFIG. 10 being used to position a patient's knee for an anterior x-rayand for a lateral x-ray, respectively;

FIG. 16 is an anterior elevation view of a patient's knee positioned inthe x-ray calibration apparatus of FIG. 10;

FIG. 17 is a side elevation view of a patient's knee positioned in thex-ray calibration apparatus of FIG. 10;

FIG. 18 is an anterior x-ray image of a patient's knee taken using thex-ray calibration apparatus of FIG. 10;

FIG. 19 is a lateral x-ray image of a patient's knee taken using thex-ray calibration apparatus of FIG. 10; and

FIG. 20 is a side elevation view of the x-ray calibration apparatus ofFIG. 10.

DETAILED DESCRIPTION OF THE DRAWINGS

While the concepts of the present disclosure are susceptible to variousmodifications and alternative forms, specific exemplary embodimentsthereof have been shown by way of example in the drawings and willherein be described in detail. It should be understood, however, thatthere is no intent to limit the concepts of the present disclosure tothe particular forms disclosed, but on the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

Terms representing anatomical references, such as anterior, posterior,medial, lateral, superior, inferior, etcetera, may be used throughoutthis disclosure in reference to the orthopaedic implants and instrumentsdescribed herein, along with a patient's natural anatomy. Such termshave well-understood meanings in both the study of anatomy and the fieldof orthopaedics. Use of such anatomical reference terms in thespecification and claims is intended to be consistent with theirwell-understood meanings unless noted otherwise.

Referring to FIG. 1, an algorithm 10 for fabricating a customizedpatient-specific orthopaedic surgical instrument is illustrated. What ismeant herein by the term “customized patient-specific orthopaedicsurgical instrument” is a surgical tool for use by a surgeon inperforming an orthopaedic surgical procedure that is intended, andconfigured, for use on a particular patient. As such, it should beappreciated that, as used herein, the term “customized patient-specificorthopaedic surgical instrument” is distinct from standard, non-patientspecific orthopaedic surgical instruments (i.e., “patient-universalinstruments” such as patient-universal cutting blocks) that are intendedfor use on a variety of different patients and were not fabricated orcustomized to any particular patient. Additionally, it should beappreciated that, as used herein, the term “customized patient-specificorthopaedic surgical instrument” is distinct from orthopaedicprostheses, whether patient-specific or generic, which are surgicallyimplanted in the body of the patient. Rather, customizedpatient-specific orthopaedic surgical instruments are used by anorthopaedic surgeon to assist in the implantation of orthopaedicprostheses. Examples of “customized patient-specific orthopaedicsurgical instruments” include customized patient-specific drill/pinguides, customized patient-specific tibial cutting blocks, andcustomized patient-specific femoral cutting blocks.

In some embodiments, the customized patient-specific orthopaedicsurgical instrument may be customized to the particular patient based onthe location at which the instrument is to be coupled to one or morebones of the patient, such as the femur and/or tibia. For example, insome embodiments, the customized patient-specific orthopaedic surgicalinstrument may include a bone-contacting or facing surface having anegative contour that matches or substantially matches the contour of aportion of the relevant bone of the patient. As such, the customizedpatient-specific orthopaedic surgical instrument is configured to becoupled to the bone of a patient in a unique location and position withrespect to the patient's bone. That is, the negative contour of thebone-contacting surface is configured to receive the matching contoursurface of the portion of the patient's bone. As such, the orthopaedicsurgeon's guesswork and/or intra-operative decision-making with respectto the placement of the orthopaedic surgical instrument are reduced. Forexample, the orthopaedic surgeon may not be required to locate landmarksof the patient's bone to facilitate the placement of the orthopaedicsurgical instrument, which typically requires some amount of estimationon part of the surgeon. Rather, the orthopaedic surgeon may simplycouple the customized patient-specific orthopaedic surgical instrumenton the bone or bones of the patient in the unique location. When socoupled, the cutting plane, drilling/pinning holes, milling holes,and/or other guides are defined in the proper location relative to thebone and intended orthopaedic prosthesis. The customizedpatient-specific orthopaedic surgical instrument may be embodied as anytype of orthopaedic surgical instrument such as, for example, abone-cutting block, a drilling/pin guide, a milling guide, or other typeof orthopaedic surgical instrument configured to be coupled to a bone ofa patient.

As shown in FIG. 1, the algorithm 10 includes process steps 12 and 14,in which an orthopaedic surgeon performs pre-operative planning of theorthopaedic surgical procedure to be performed on a patient. The processsteps 12 and 14 may be performed in any order or contemporaneously witheach other. In process step 12, a number of medical images of therelevant bony anatomy or joint of the patient are generated. To do so,the orthopaedic surgeon or other healthcare provider may operate animaging system to generate the medical images. The medical images may beembodied as any number and type of medical images capable of being usedto generate a three-dimensional rendered model of the patient's bonyanatomy or relevant joint. For example, the medical images may beembodied as any number of computed tomography (CT) images, magneticresonance imaging (MRI) images, or other three-dimensional medicalimages. Additionally or alternatively, as discussed in more detail belowin regard to process step 18, the medical images may be embodied as anumber of X-ray images or other two-dimensional images from which athree-dimensional rendered model of the patient's relevant bony anatomymay be generated. Additionally, in some embodiments, the medical imagemay be enhanced with a contrast agent designed to highlight thecartilage surface of the patient's knee joint.

In process step 14, the orthopaedic surgeon may determine any additionalpre-operative constraint data. The constraint data may be based on theorthopaedic surgeon's preferences, preferences of the patient,anatomical aspects of the patient, guidelines established by thehealthcare facility, or the like. For example, the constraint data mayinclude the orthopaedic surgeon's preference for a metal-on-metalinterface, amount of inclination for implantation, the thickness of thebone to resect, size range of the orthopaedic implant, and/or the like.In some embodiments, the orthopaedic surgeon's preferences are saved asa surgeon's profile, which may used as a default constraint values forfurther surgical plans.

In process step 16, the medical images and the constraint data, if any,are transmitted or otherwise provided to an orthopaedic surgicalinstrument vendor or manufacturer. The medical images and the constraintdata may be transmitted to the vendor via electronic means such as anetwork or the like. After the vendor has received the medical imagesand the constraint data, the vendor processes the images in step 18. Theorthopaedic surgical instrument vendor or manufacturer process themedical images to facilitate the determination of the bone cuttingplanes, implant sizing, and fabrication of the customizedpatient-specific orthopaedic surgical instrument as discussed in moredetail below. For example, in process step 20 the vendor may convert orotherwise generate three-dimensional images from the medical images. Forexample, in embodiments wherein the medical images are embodied as anumber of two-dimensional images, the vendor may use a suitable computeralgorithm to generate one or more three-dimensional images form thenumber of two-dimensional images. Additionally, in some embodiments, themedical images may be generated based on an established standard such asthe Digital Imaging and Communications in Medicine (DICOM) standard. Insuch embodiments, an edge-detection, thresholding, watershead, orshape-matching algorithm may be used to convert or reconstruct images toa format acceptable in a computer aided design application or otherimage processing application. Further, in some embodiments, an algorithmmay be used to account for tissue such as cartilage not discernable inthe generated medical images. In such embodiments, any three-dimensionalmodel of the patient-specific instrument (see, e.g., process step 26below) may be modified according to such algorithm to increase the fitand function of the instrument.

In process step 22, the vendor may process the medical images, and/orthe converted/reconstructed images from process step 20, to determine anumber of aspects related to the bony anatomy of the patient such as theanatomical axis of the patient's bones, the mechanical axis of thepatient's bone, other axes and various landmarks, and/or other aspectsof the patient's bony anatomy. To do so, the vendor may use any suitablealgorithm to process the images.

In process step 24, the cutting planes of the patient's bone aredetermined. The planned cutting planes are determined based on the type,size, and position of the orthopaedic prosthesis to be used during theorthopaedic surgical procedure, on the process images such as specificlandmarks identified in the images, and on the constraint data suppliedby the orthopaedic surgeon in process steps 14 and 16. The type and/orsize of the orthopaedic prosthesis may be determined based on thepatient's anatomy and the constraint data. For example, the constraintdata may dictate the type, make, model, size, or other characteristic ofthe orthopaedic prosthesis. The selection of the orthopaedic prosthesismay also be modified based on the medical images such that anorthopaedic prosthesis that is usable with the bony anatomy of thepatient and that matches the constraint data or preferences of theorthopaedic surgeon is selected.

In addition to the type and size of the orthopaedic prosthesis, theplanned location and position of the orthopaedic prosthesis relative tothe patient's bony anatomy is determined. To do so, a digital templateof the selected orthopaedic prosthesis may be overlaid onto one or moreof the processed medical images. The vendor may use any suitablealgorithm to determine a recommended location and orientation of theorthopaedic prosthesis (i.e., the digital template) with respect to thepatient's bone based on the processed medical images (e.g., landmarks ofthe patient's bone defined in the images) and/or the constraint data.Additionally, any one or more other aspects of the patient's bonyanatomy may be used to determine the proper positioning of the digitaltemplate.

In some embodiments, the digital template along with surgical alignmentparameters may be presented to the orthopaedic surgeon for approval. Theapproval document may include the implant's rotation with respect tobony landmarks such as the femoral epicondyle, posterior condyles,sulcus groove (Whiteside's line), and the mechanical axis as defined bythe hip, knee, and/or ankle centers.

The planned cutting planes for the patient's bone(s) may then bedetermined based on the determined size, location, and orientation ofthe orthopaedic prosthesis. In addition, other aspects of the patient'sbony anatomy, as determined in process step 22, may be used to determineor adjust the planned cutting planes. For example, the determinedmechanical axis, landmarks, and/or other determined aspects of therelevant bones of the patient may be used to determine the plannedcutting planes.

In process step 26, a model of the customized patient-specificorthopaedic surgical instrument is generated. In some embodiments, themodel is embodied as a three-dimensional rendering of the customizedpatient-specific orthopaedic surgical instrument. In other embodiments,the model may be embodied as a mock-up or fast prototype of thecustomized patient-specific orthopaedic surgical instrument. Theparticular type of orthopaedic surgical instrument to be modeled andfabricated may be determined based on the orthopaedic surgical procedureto be performed, the constraint data, and/or the type of orthopaedicprosthesis to be implanted in the patient. As such, the customizedpatient-specific orthopaedic surgical instrument may be embodied as anytype of orthopaedic surgical instrument for use in the performance of anorthopaedic surgical procedure. For example, the orthopaedic surgicalinstrument may be embodied as a bone-cutting block, a drilling/pinningguide, a milling guide, and/or any other type of orthopaedic surgicaltool or instrument.

The particular shape of the customized patient-specific orthopaedicsurgical instrument is determined based on the planned location of theorthopaedic surgical instrument relative to the patient's bony anatomy.The location of the customized patient-specific orthopaedic surgicalinstrument with respect to the patient's bony anatomy is determinedbased on the type and determined location of the orthopaedic prosthesisto be used during the orthopaedic surgical procedure. That is, theplanned location of the customized patient-specific orthopaedic surgicalinstrument relative to the patient's bony anatomy may be selected basedon, in part, the planned cutting planes of the patient's bone(s) asdetermined in step 24. For example, in embodiments wherein thecustomized patient-specific orthopaedic surgical instrument is embodiedas a drilling/pinning guide (or hereinafter, simply a “pin guide”) foruse in conjunction with a patient-universal cutting block, the locationof the orthopaedic surgical instrument is selected such that the cuttingguide of the patient-universal cutting block, when installed on guidepins placed in the bone by use of the customized patient-specific pinguide, matches one or more of the planned cutting planes determined inprocess step 24. Additionally, the planned location of the orthopaedicsurgical instrument may be based on the identified landmarks of thepatient's bone identified in process step 22.

In some embodiments, the particular shape or configuration of thecustomized patient-specific orthopaedic surgical instrument may bedetermined based on the planned location of the instrument relative tothe patient's bony anatomy. That is, the customized patient-specificorthopaedic surgical instrument may include a bone-contacting surfacehaving a negative contour that matches the contour of a portion of thebony anatomy of the patient such that the orthopaedic surgicalinstrument may be coupled to the bony anatomy of the patient in a uniquelocation, which corresponds to the pre-planned location for theinstrument. When the orthopaedic surgical instrument is coupled to thepatient's bony anatomy in the unique location, one or more guides (e.g.,cutting or drilling guide) of the orthopaedic surgical instrument may bealigned to one or more of the bone cutting plane(s) as discussed above.

One illustrative embodiment of a method 40 for generating a model, suchas a computer model, of a patient-specific orthopaedic instrument isillustrated in FIGS. 2 through 9. The method 40 begins with a step 42 inwhich a cartilage thickness value is determined. The cartilage thicknessvalue is indicative of the average thickness of the cartilage of thepatient's bone. As such, in one embodiment, the cartilage thicknessvalue is equal to the average thickness of cartilage for an individualhaving similar characteristics as the patient. For example, thecartilage thickness value may be equal to the average thickness value ofindividuals of the same gender as the patient, the same age as thepatient, having the same activity level of the patient, and/or the like.In other embodiments, the cartilage thickness value is determined basedon one or more medical images of the patient's bone, such as thoseimages transmitted in process step 16.

In step 44, a reference contour of the patient's relevant bone isdetermined. The reference contour is based on the surface contour of athree-dimensional model of the patient's relevant bone, such as thethree-dimensional model generated in step 20. Initially the referencecontour is identical to a region (i.e. the region of interest such asthe distal end of the patient's femur or the proximal end of thepatient's tibia) of the patient's bone. That is, in some embodiments,the reference contour is juxtaposed on the surface contour of the regionof the patient's bone.

Subsequently, in step 46, the reference contour is scaled to compensatefor the cartilage thickness value determined in step 42. To do so, inone embodiment, the scale of the reference contour is increased based onthe cartilage thickness value. For example, the scale of the referencecontour may be increased by an amount equal to or determined from thecartilage thickness value. However, in other embodiments, the referencecontour may be scaled using other techniques designed to scale thereference contour to a size at which the reference contour iscompensated for the thickness of the cartilage on the patient's bone.

For example, in one particular embodiment, the reference contour isscaled by increasing the distance between a fixed reference point and apoint lying on, and defining in part, the reference contour. To do so,in one embodiment, a method 60 for scaling a reference contour asillustrated in FIG. 3 may be used. The method 60 begins with step 62 inwhich a medial/lateral line segment is established on thethree-dimensional model of the patient's relevant bone. Themedial/lateral line segment is defined or otherwise selected so as toextend from a point lying on the medial surface of the patient's bone toa point lying on lateral surface of the patient's bone. The medialsurface point and the lateral surface point may be selected so as todefine the substantially maximum local medial/lateral width of thepatient's bone in some embodiments.

In step 64, an anterior/posterior line segment is established on thethree-dimensional model of the patient's relevant bone. Theanterior/posterior line segment is defined or otherwise selected so asto extend from a point lying on the anterior surface of the patient'sbone to a point lying on posterior surface of the patient's bone. Theanterior surface point and the posterior surface point may be selectedso as to define the substantially maximum local anterior/posterior widthof the patient's bone in some embodiments.

The reference point from which the reference contour will be scaled isdefined in step 66 as the intersection point of the medial/lateral linesegment and anterior/posterior line segment. As such, it should beappreciated that the medial surface point, the lateral surface point,the anterior surface point, and the posterior surface point lie on thesame plane. After the reference point is initially established in step66, the reference point is moved or otherwise translated toward an endof the patient's bone. For example, in embodiments wherein the patient'sbone is embodied as a femur, the reference point is moved inferiorlytoward the distal end of the patient's femur. Conversely, in embodimentswhen the patient's bone is embodied as a tibia, the reference point ismoved superiorly toward the proximal end of the patient's tibia. In oneembodiment, the reference point is moved a distance equal to about halfthe length of the anterior/posterior line segment as determined in step64. However, in other embodiments, the reference point may be movedother distances sufficient to compensate the reference contour forthickness of the cartilage present on the patient's bone.

Once the location of the reference point has been determined in step 68,the distance between the reference point and each point lying on, anddefining in part, the reference contour is increased in step 70. To doso, in one particular embodiment, each point of the reference contour ismoved a distance away from the reference point based on a percentagevalue of the original distance defined between the reference point andthe particular point on the reference contour. For example, in oneembodiment, each point lying on, and defining in part, the referencecontour is moved away from the reference point in by a distance equal toa percentage value of the original distance between the reference pointand the particular point. In one embodiment, the percentage value is inthe range of about five percent to about thirty percent. In oneparticular embodiment, the percentage value is about ten percent.

Referring now to FIGS. 4-9, in another embodiment, the reference contouris scaled by manually selecting a local “high” point on the surfacecontour of the three-dimensional image of the patient's bone. Forexample, in embodiments wherein the relevant patient's bone is embodiedas a tibia as illustrated in FIGS. 4-6, the reference point 90 isinitially located on the tibial plateau high point of the tibial model92. Either side of the tibial plateau may be used. Once the referencepoint 90 is initially established on the tibial plateau high point, thereference point 90 is translated to the approximate center of theplateau as illustrated in FIG. 5 such that the Z-axis defining thereference point is parallel to the mechanical axis of the tibial model92. Subsequently, as illustrated in FIG. 6, the reference point is movedin the distal direction by a predetermined amount. In one particularembodiment, the reference point is moved is the distal direction byabout 20 millimeters, but other distances may be used in otherembodiments. For example, the distance over which the reference point ismoved may be based on the cartilage thickness value in some embodiments.

Conversely, in embodiments wherein the relevant patient's bone isembodied as a femur as illustrated in FIGS. 7-9, the reference point 90is initially located on the most distal point of the distal end of thefemoral model 94. Either condyle of the femoral model 94 may be used invarious embodiments. Once the reference point 90 is initiallyestablished on the most distal point, the reference point 90 istranslated to the approximate center of the distal end of the femoralmodel 94 as illustrated in FIG. 8 such that the Z-axis defining thereference point 90 is parallel to the mechanical axis of the femoralmodel 92. The anterior-posterior width 96 of the distal end of thefemoral model 94 is also determined. Subsequently, as illustrated inFIG. 9, the reference point is moved or otherwise translated in theproximal or superior direction by a distance 98. In one particularembodiment, the reference point is moved in the distal or superiordirection by a distance 98 equal to about half the distance 96. As such,it should be appreciated that one of a number of different techniquesmay be used to define the location of the reference point based on, forexample, the type of bone.

Referring now back to FIG. 2, once the reference contour has been scaledin step 46, the medial/lateral sides of the reference contour areadjusted in step 48. To do so, in one embodiment, the distance betweenthe reference point and each point lying on, and defining in part, themedial side and lateral side of the reference contour is decreased. Forexample, in some embodiments, the distance between the reference pointand the points on the medial and lateral sides of the scaled referencecontour are decreased to the original distance between such points. Assuch, it should be appreciated that the reference contour is offset orotherwise enlarged with respect to the anterior side of the patient'sbone and substantially matches or is otherwise not scaled with respectto the medial and lateral sides of the patient's bone.

The reference contour may also be adjusted in step 48 for areas of thepatient's bone having a reduced thickness of cartilage. Such areas ofreduced cartilage thickness may be determined based on the existence ofbone-on-bone contact as identified in a medical image, simulation, orthe like. Additionally, information indicative of such areas may beprovided by the orthopaedic surgeon based on his/her expertise. If oneor more areas of reduced cartilage thickness are identified, thereference contour corresponding to such areas of the patient's bone isreduced (i.e., scaled back or down).

Additionally, in some embodiments, one or more osteophytes on thepatient's bone may be identified; and the reference contour may becompensated for such presence of the osteophytes. By compensating forsuch osteophytes, the reference contour more closely matches the surfacecontour of the patient's bone. Further, in some embodiments, a distalend (in embodiments wherein the patient's bone is embodied as a tibia)or a proximal end (in embodiments wherein the patient's bone is embodiedas a femur) of the reference contour may be adjusted to increase theconformity of the reference contour to the surface contour of the bone.For example, in embodiments wherein the patient's bone is a femur, thesuperior end of the scaled reference contour may be reduced or otherwisemoved closer to the surface contour of the patient's femur in the regionlocated superiorly to a cartilage demarcation line defined on thepatient's femur. Conversely, in embodiments wherein the patient's boneis embodied as a tibia, an inferior end of the scaled reference contourmay be reduced or otherwise moved closer to the surface contour of thepatient's tibia in the region located inferiorly to a cartilagedemarcation line of the patient's tibia. As such, it should beappreciated that the scaled reference contour is initially enlarged tocompensate for the thickness of the patient's cartilage on the patient'sbone. Portions of the scaled reference contour are then reduced orotherwise moved back to original positions and/or toward the referencepoint in those areas where cartilage is lacking, reduced, or otherwisenot present.

Once the reference contour has been scaled and adjusted in steps 46 and48, the position of the cutting guide is defined in step 50. Inparticular, the position of the cutting guide is defined based on anangle defined between a mechanical axis of the patient's femur and amechanical axis of the patient's tibia. The angle may be determined byestablishing a line segment or ray originating from the proximal end ofthe patient's femur to the distal end of the patient's femur anddefining a second line segment or ray extending from the patient's anklethrough the proximal end of the patient's tibia. The angle defined bythese two line segments/rays is equal to the angle defined between themechanical axis of the patient's femur and tibia. The position of thebone cutting guide is then determined based on the angle between themechanical axes of the patient's femur and tibia. It should beappreciated that, as will be discussed below in more detail, theposition of the cutting guide defines the position and orientation ofthe cutting plane of a patient-universal cutting block when it isinstalled on guide pins placed in the bone by use of a customizedpatient-specific pin guide. Subsequently, in step 52, a negative contourof the customized patient-specific pin guide is defined based on thescaled and adjusted reference contour and the angle defined between themechanical axis of the femur and tibia.

Referring back to FIG. 1, after the model of the customizedpatient-specific orthopaedic surgical instrument has been generated inprocess step 26, the model is validated in process step 28. The modelmay be validated by, for example, analyzing the rendered model whilecoupled to the three-dimensional model of the patient's anatomy toverify the correlation of cutting guides and planes, drilling guides andplanned drill points, and/or the like. Additionally, the model may bevalidated by transmitting or otherwise providing the model generated instep 26 to the orthopaedic surgeon for review. For example, inembodiments wherein the model is a three-dimensional rendered model, themodel along with the three-dimensional images of the patient's relevantbone(s) may be transmitted to the surgeon for review. In embodimentswherein the model is a physical prototype, the model may be shipped tothe orthopaedic surgeon for validation.

After the model has been validated in process step 28, the customizedpatient-specific orthopaedic surgical instrument is fabricated inprocess step 30. The customized patient-specific orthopaedic surgicalinstrument may be fabricated using any suitable fabrication device andmethod. Additionally, the customized patient-specific orthopaedicinstrument may be formed from any suitable material such as a metallicmaterial, a plastic material, or combination thereof depending on, forexample, the intended use of the instrument. The fabricated customizedpatient-specific orthopaedic instrument is subsequently shipped orotherwise provided to the orthopaedic surgeon. The surgeon performs theorthopaedic surgical procedure in process step 32 using the customizedpatient-specific orthopaedic surgical instrument. As discussed above,because the orthopaedic surgeon does not need to determine the properlocation of the orthopaedic surgical instrument intra-operatively, whichtypically requires some amount of estimation on part of the surgeon, theguesswork and/or intra-operative decision-making on part of theorthopaedic surgeon is reduced.

Referring now to FIGS. 10-11, an x-ray calibration apparatus 100 isillustrated. As will be described below in greater detail, the x-raycalibration apparatus 100 enables x-ray imaging and accuratethree-dimensional reconstruction of a patient's bony anatomy. The x-raycalibration apparatus 100 includes a radiolucent knee alignment jig 102and a radiolucent cushion 104. The radiolucent knee alignment jig 102 isformed from a radiolucent plastic and is configured to receive apatient's knee 130. The knee alignment jig 102 includes a bottom plate106, a lateral sidewall 108, and a medial sidewall 110. The lateralsidewall 108 and the medial sidewall 110 are secured to and extendupwardly from the bottom plate 106. In the illustrative embodimentdescribed herein, the medial sidewall 110 is shorter than the lateralsidewall 108. The lateral sidewall 108 may be marked with intersectingperpendicular lines configured to be aligned with cross-hairs emitted byan x-ray source positioned to create an x-ray image takenperpendicularly to the sidewall. The bottom plate 106 includes a bottomsurface 111 and an upper surface 112 configured to hold the radiolucentcushion 104. It should be appreciated that the x-ray calibrationapparatus is intended to be suitable for use with patients having kneesand bony anatomy of many different sizes. The bottom plate 106 is thussufficiently wide to comfortably fit the knee of nearly any patientbetween the lateral sidewall 108 and the medial sidewall 110.

The radiolucent cushion 104 is secured to the upper surface 112 of thebottom plate 106 and positioned between the lateral sidewall 108 and themedial sidewall 110 of the radiolucent knee alignment jig 102. Theradiolucent cushion 104 contains an upper ridge 114 and is angled tohold a patient's knee 130 at a fixed angle of flexion. In an embodiment,a knee flexion of approximately 5-10 may be used for x-ray imaging ofthe knee. The radiolucent cushion 104 is also configured to hold thepatient's knee 130 at a fixed distance above the x-ray table, as shownin FIG. 17. The radiolucent cushion 104 is made of a soft material so asto be comfortable to the patient. The radiolucent cushion 104 may bemarked with instructions useful to the x-ray technician or otherhealthcare provider in the placement of the x-ray calibration apparatus100 and in placement of a patient's knee 130. The radiolucent cushion104 may also be marked with intersecting perpendicular lines configuredto be aligned with cross-hairs emitted by an x-ray source positioned tocreate an x-ray image taken perpendicularly to the bottom plate 106.

As depicted in FIGS. 12-13, as well as in FIGS. 17 and 20, within theradiolucent lateral sidewall 108 and the radiolucent medial sidewall 110there are located a plurality of fiducial markers 116. The fiducialmarkers 116 are radio-opaque such that when viewed on x-ray images of apatient's knee 130 in the x-ray calibration apparatus 100, therepresentations 138 of the fiducial markers 116 provide registrationpoints that can be used to calculate the x-ray scaling factor and beamangle and to register multiple x-ray images onto one another. Thefiducial markers 116 may be made of any radio-opaque material. In theillustrative embodiment described herein, the fiducial markers 116 areembodied as metal ball bearings.

In the illustrative embodiment described herein, the lateral sidewall108 and medial sidewall 110 have a number of blind bores 118 formedtherein. Embedded within each of the blind bores 118 is one of thefiducial markers 116. The remainder of each of the blind bores 118 isfilled with a radiolucent material such as a plastic plug or the like.In other embodiments, the fiducial markers 116 may be embedded in thelateral sidewall 108 and the medial sidewall 110 by other means. Itshould be understood that however the fiducial markers 116 are embedded,they are held rigidly in position within the lateral sidewall 108 andthe medial sidewall 110.

In the illustrative embodiment described herein, there are ten fiducialmarkers 116. As illustrated in FIGS. 12 and 20, three fiducial markers116 are embedded near the top of the lateral sidewall 108. Of thesethree markers, two are located towards the distal edge 120 of thelateral sidewall 108 and the other is located towards the proximal edge122 of the lateral sidewall 108.

As illustrated in FIGS. 17 and 20, three fiducial markers 116 areembedded near the bottom of the lateral sidewall 108. Of these threemarkers, two are located towards the proximal edge 122 of the lateralsidewall 108 and the other is located towards the distal edge 120 of thelateral sidewall 108.

As illustrated in FIGS. 12, 17, and 20, the remaining four fiducialmarkers 116 are embedded within the medial sidewall 110. Of these fourmarkers, two are located towards the proximal edge 124 of the medialsidewall 110 and the other two are located towards the distal edge 126of the medial sidewall 110.

While the positions of the fiducial markers 116 in the illustrativeembodiment described herein have been described in detail, otherarrangements may be used given the needs of different modeling systems,given the need for more or fewer registration points on x-ray images, orgiven the need for registration points in different locations on x-rayimages. However, it should be understood that, when viewed on x-rayimages taken in a direction anterior to the patient's knee 130 or in adirection lateral to the patient's knee 130, none of the fiducialmarkers 116 overlaps with any other fiducial marker or with the bonyanatomy of the patient. Further, in such an embodiment some fiducialmarkers 116 are in front of the bony anatomy and others are behind thebony anatomy in both anterior and lateral views.

It should be appreciated that the x-ray calibration apparatus 100 issuitable for use with patients having knees and bony anatomy of manydifferent sizes. Thus, fiducial markers 116 embedded near the top of thelateral sidewall are positioned high enough to appear above the bonyanatomy of a given patient's knee when the marker's representations areviewed on a lateral x-ray image. Similarly, the fiducial markers 116embedded within the medial sidewall 110 and those embedded near thebottom of the lateral sidewall 108 are positioned low enough to appearbelow the bony anatomy of a given patient's knee when the marker'srepresentations are viewed on a lateral x-ray image.

As described above, the radiolucent cushion 104 functions to hold thepatient's knee 130 at a fixed distance above the x-ray table. As such,the radiolucent cushion is configured to hold the patient's knee 130high enough off the table so that representations 138 of the fiducialmarkers 116 embedded within the medial sidewall 110 and of thoseembedded near the bottom of the lateral sidewall 108 appear below thepatient's knee 130 when viewed on a lateral x-ray image 140 such as thatshown in FIG. 19.

As shown in FIGS. 14-17, a patient 128 may be positioned with thepatient's knee 130 in the x-ray calibration apparatus 100. Asillustrated, the x-ray calibration apparatus 100 is positioned such thatthe lateral sidewall 108 is positioned outside the lateral side of thepatient's knee 130, and the medial sidewall 110 is positioned outsidethe medial side of the patient's knee 130. As shown in FIGS. 14 and 16,an x-ray machine 132 and an x-ray cassette 134 may be positioned toacquire an x-ray image taken in a direction anterior to the patient'sknee 130. As can be seen in FIGS. 15 and 17, the x-ray machine 132 andthe x-ray cassette 134 may also be positioned to acquire an x-ray imagetaken in a direction lateral to the patient's knee.

Referring now to FIG. 18, an anterior x-ray image 136 is taken in adirection anterior to a patient's knee 130. The anterior x-ray image 136includes representations 138 of the fiducial markers 116. There are fourrepresentations 138 medial to the bony anatomy of the patient's knee130, with such representations 138 corresponding to the four fiducialmarkers 116 located in the medial sidewall 110 of the illustrativeembodiment described herein. As can also be seen in FIG. 18, sixrepresentations 138 are located laterally to the bony anatomy of thepatient's knee 130, with such representations 138 corresponding to thesix fiducial markers 116 located in the lateral sidewall 108 of theillustrative embodiment described herein. As can be seen, none of therepresentations 138 of the fiducial markers 116 overlaps with any of theother representations 138 or with the bony anatomy of the patient's knee130 when viewed on an anterior x-ray image 136.

A lateral x-ray image 140 taken in a direction lateral to the patient'sknee 130 is shown in FIG. 19. Like the anterior x-ray of FIG. 18, thelateral x-ray image 140 also includes representations 138 of thefiducial markers 116. For example, three representations 138 are shownlocated above the bony anatomy of the patient's knee 130, with suchrepresentations 138 corresponding to the three fiducial markers 116located near the top of the lateral sidewall 108 of the illustrativeembodiment described herein. As can also be seen in FIG. 19, sevenrepresentations 138 are located below the bony anatomy of the patient'sknee 130. These seven representations 138 correspond to the fourfiducial markers 116 located in the medial sidewall 110 and the threefiducial markers 116 located near the bottom of the lateral sidewall 108of the illustrative embodiment described herein.

Using x-ray images of a patient's knee, such as those depicted in FIGS.18 and 19, the x-ray scaling factor and beam angle can be calculated,and a three-dimensional image can be generated for use in thefabrication of a customized patient-specific orthopaedic kneeinstrument. The patient's knee is first positioned within the x-raycalibration apparatus 100 and properly aligned according to instructionsprovided therewith. As depicted in FIG. 14, an x-ray image is taken in adirection anterior to the patient's knee, resulting in an anterior x-rayimage such as that shown in FIG. 18. As depicted in FIG. 15, an x-rayimage is also taken in a direction lateral to the patient's knee,resulting in a lateral x-ray image such as that shown in FIG. 19. Usingthe representations 138 of the fiducial markers 116 as commonregistration points, the two x-ray images are then registered onto oneanother.

To calculate the x-ray scaling factor, the distances between two or moreselected representations 138 of the fiducial markers 116 in either orboth x-ray images are measured. These distances are then compared to thedistances between the corresponding fiducial markers 116 in the x-raycalibration apparatus 100. The ratio of the distance betweenrepresentations 138 over the distance between the corresponding fiducialmarkers 116 is equal to the x-ray scaling factor.

To calculate beam angle, the distances between two or more sets ofrepresentations 138 of the fiducial markers 116 in either or both x-rayimages are measured. These distances are then compared to the distancesbetween the corresponding fiducial markers 116 positioned in the x-raycalibration apparatus 100.

By registering the anterior and lateral x-ray images onto one another, athree-dimensional reconstruction of the patient's bony anatomy can becreated. As described above in regard to FIGS. 1-9, suchthree-dimensional reconstruction of bony anatomy is used in creatingpatient-specific instruments. For example, one embodiment of the use ofsuch three-dimensional images is described above in regard to processstep 12.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, such an illustration and descriptionis to be considered as exemplary and not restrictive in character, itbeing understood that only illustrative embodiments have been shown anddescribed and that all changes and modifications that come within thespirit of the disclosure are desired to be protected. In particular, itis contemplated that the x-ray calibration apparatus, described abovefor use in generating x-ray images of a patient's knee, may also be usedto generate x-ray images of other parts of a patient's anatomy.

There are a plurality of advantages of the present disclosure arisingfrom the various features of the apparatus, system, and method describedherein. It will be noted that alternative embodiments of the apparatus,system, and method of the present disclosure may not include all of thefeatures described yet still benefit from at least some of theadvantages of such features. Those of ordinary skill in the art mayreadily devise their own implementations of the apparatus, system, andmethod that incorporate one or more of the features of the presentinvention and fall within the spirit and scope of the present disclosureas defined by the appended claims.

What is claimed is:
 1. A method of generating an image for use in thefabrication of a customized patient-specific orthopaedic kneeinstrument, comprising: positioning a patient's knee on a radiolucentcushion of an x-ray calibration apparatus at a fixed angle of flexion,the x-ray calibration apparatus having a plurality of radio-opaquefiducial markers positioned at fixed distances such that each of theplurality of radio-opaque fiducial markers are distinct from one anotherwhen viewed in x-ray images taken (i) in a direction anterior to thepatient's knee, and (ii) in a direction lateral to the patient's knee,taking a first x-ray image in a direction anterior to the patient's kneesuch that representations of at least some of the plurality ofradio-opaque fiducial markers are visible in the first x-ray image,taking a second x-ray image perpendicularly to a lateral sidewall of thex-ray calibration apparatus in a direction lateral to the patient's kneesuch that representations of at least some of the plurality ofradio-opaque fiducial markers are visible in the second x-ray image,registering the first and second x-ray images onto one another using therepresentations of the plurality of radio-opaque fiducial markersvisible in the first and second x-ray images, wherein the at least someof the plurality of radio-opaque fiducial markers visible in the secondx-ray image include (i) an upper plurality of radio-opaque fiducialmarkers that appear above an upper ridge of the radiolucent cushion and(ii) a lower plurality of radio-opaque fiducial markers that appearbelow the upper ridge of the radiolucent cushion.
 2. The method of claim1, wherein registering the first and second x-ray images comprisesaligning the first and second x-ray images using the representations ofthe plurality of radio-opaque fiducial markers visible in the first andsecond x-ray images.
 3. The method of claim 1, further comprising:calculating an x-ray scaling factor by (i) measuring the distancesbetween two or more of the representations of the plurality ofradio-opaque fiducial markers visible in one or both of the first andsecond x-ray images, and (ii) comparing the distances between the two ormore of the representations of the plurality of radio-opaque fiducialmarkers visible in one or both of the first and second x-ray images tothe distances between the corresponding fiducial markers positioned inthe x-ray calibration apparatus.
 4. The method of claim 1, furthercomprising: calculating a beam angle by (i) measuring the distancesbetween two or more sets of representations of the plurality ofradio-opaque fiducial markers visible in one or both of the first andsecond x-ray images, and (ii) comparing the distances between the two ormore of the representations of the plurality of radio-opaque fiducialmarkers visible in one or both of the first and second x-ray images tothe distances between the corresponding fiducial markers positioned inthe x-ray calibration apparatus.
 5. The method of claim 1, furthercomprising: calculating an x-ray scaling factor by (i) measuring thedistance between a first representation of a first of the plurality ofradio-opaque fiducial markers visible in the first x-ray image and asecond representation of a second of the plurality of radio-opaquefiducial markers visible in the first x-ray image, and (ii) comparingthe distance between the first and second representations to thedistance between the first fiducial marker positioned in the x-raycalibration apparatus and the second fiducial marker positioned in thex-ray calibration apparatus.
 6. The method of claim 1, furthercomprising: calculating an x-ray scaling factor by (i) measuring thedistance between a first representation of a first of the plurality ofradio-opaque fiducial markers visible in the second x-ray image and asecond representation of a second of the plurality of radio-opaquefiducial markers visible in the second x-ray image, and (ii) comparingthe distance between the first and second representations to thedistance between the first fiducial marker positioned in the x-raycalibration apparatus and the second fiducial marker positioned in thex-ray calibration apparatus.
 7. The method of claim 1, furthercomprising: calculating a beam angle by (i) measuring the distancesbetween two or more sets of representations of the plurality ofradio-opaque fiducial markers visible in the first x-ray image, and (ii)comparing the distances between the two or more of the representationsof the plurality of radio-opaque fiducial markers visible in the firstx-ray image to the distances between the corresponding fiducial markerspositioned in the x-ray calibration apparatus.
 8. The method of claim 1,further comprising: calculating a beam angle by (i) measuring thedistances between two or more sets of representations of the pluralityof radio-opaque fiducial markers visible in the second x-ray image, and(ii) comparing the distances between the two or more of therepresentations of the plurality of radio-opaque fiducial markersvisible in the second x-ray image to the distances between thecorresponding fiducial markers positioned in the x-ray calibrationapparatus.
 9. The method of claim 1, further comprising generating adesign of the customized, patient-specific orthopaedic knee instrumentbased on the registered first and second x-ray images.